Doxycycline hyclate tablets, USP equivalent to 100 mg of doxycycline: Beige color, round convex, film coated tablets debossed “312” below, “B” on one side and plain on the other.
Bottles of 50 tablets NDC 42806-312-50
Bottles of 100 tablets NDC 42806-312-01
Bottles of 500 tablets NDC 42806-312-05
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.
Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.
Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.
- Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
- Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
- Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
- Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.
Epic Pharma, LLC
Laurelton, NY 11413 USA
Product of USA
Epic Doxycycline Hyclate Tablets, USP
100 mg 50 Tablets
| DOXYCYCLINE HYCLATE |
doxycycline hyclate tablet, film coated
|Labeler — Epic Pharma, LLC (827915443)|
|Registrant — Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe (080230346)|
|Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe||080230346||MANUFACTURE (42806-312)|
Revised: 07/2020 Epic Pharma, LLC
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